Presentations of Hyperandrogenic Phenotypes in Taiwanese Women

STUDY QUESTION: Which of the four abnormally elevated androgen groups (total testosterone [TT], androstenedione [A4], free androgen index [FAI], or dehydroepiandrosterone-sulfate [DHEA-S]) present with an unfavorable metabolic and hormonal profile, appear to be more insulin-resistant and pose additional cardiovascular risk? SUMMARY ANSWER: Subjects with excess free androgen index tend to be obese and face the highest metabolic syndrome risk, adipocytokine alterations, insulin resistance (IR) and cardiovascular risk. The excess TT group presents with a marginal IR risk, while the excess A4 group has the highest antimüllerian hormone (AMH), and may counterbalance obesity; this group and the excess DHEA-S group have a favorable association with IR.

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Key information

Conditions

Hyperandrogenism, 46, XX Disorders of Sex Development Adnexal Diseases Adrenogenital Syndrome Cardiovascular Disease. Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cysts Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperandrogenism Hyperinsulinism Insulin Resistance Insulin Resistance, Male Urogenital Diseases Metabolic Diseases Metabolic Syndrome Metabolic Syndrome, Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Polycystic Ovary Syndrome, Urogenital Abnormalities Urogenital Diseases

Age range

13 year–48 year

Sex eligibility

Female

Study type

Observational

Primary location

WanFang Medical Center at Taipei Medical University

Taipei, Taiwan, 116

About this study

STUDY DESIGN, SIZE, DURATION:A retrospective study in 160 Taiwanese women with HA and 165 women without HA, with medical records reviewed from 2009 up to 2012. The hyperandrogenic women were classified into four groups (TT, A4, FAI, and DHEA-S) according to independent abnormally elevated androgen measures each above its cut-off value, and the groups were compared with each other and with controls.

PARTICIPANTS/MATERIALS, SETTING, METHODS: This study was performed in the Reproductive Endocrinology Clinic at Wan Fang Medical Center in Taipei, Taiwan. Anthropometric, metabolic, endocrine, and IR components as well as lipid accumulation product (LAP) index were compared between the groups. IR was assessed with the following markers: fasting glucose and insulin levels, oral glucose tolerance test, glucose-to-insulin ratio and homeostasis model assessment of IR index (HOMA-IR).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hyperandrogenic women who were classified into four groups:

Total testosterone (TT),
Androstenedione (A4),
Free androgen index (FAI),
and Dehydroepiandrosterone sulphate(DHEA-S).
According to abnormally elevated androgen measures each above its cut-off value, and non hyperandrogenic women (who had all androgens below their cut-off values)

Exclusion criteria

None of the women studied had

Hypogonadotropic hypogondism,
Hyperprolactinemia,
Congenital adrenal hyperplasia,
Premature ovarian failure,
Androgen-secreting tumors,
Cushing's syndrome,
or any other endocrine or systemic disease that may affect the reproductive function,
or any disorders of the uterus (e.g. Asherman's syndrome and Mullerian genesis) and chromosomal anomalies (e.g. Turner's syndrome).
In addition, we excluded females who had

Experienced menarche less than three years preceding the study start,
or who had day 3 FSH > 15 mIU/ml, as well as women with insufficient clinical/biochemical records,
and women with ovarian cysts or tumors in an ultrasonographic examination.

Treatment and study plan

Primary outcomes

Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women

Time frame: A retrospective study in 160 Taiwanese women with HA and 165 women without HA, with medical records reviewed from January 1, 2009, through July 21, 2012 (up to 3.5 years)

Androgens (Total Testosterone (TT) (nmol/L), androstenedione (A4)(ng/ml), free androgen index (FAI), and dehydroepiandrosterone sulfate (DHEA-S) (µg/dl ); anthroponmetric components (body mass index (BMI)(Kg/m2) , waist (cm), Waist-to-hip ratio (W/H)); average menstrual interval, antimullerian hormone(AMH)(ng/ml) adiponectin (ng/nl), leptin(ng/ml), adiponectin/leptin (A/L) ratio, and insulin resistance markers( fasting insulin (µIU/ml), glucose-to-insulin ratio (GIR), Homeostasis model assessment insulin resistance (HOMA-IR) Index, Lipid Accumulation Product Index (LAP Index)).

Sponsors and collaborators

Lead sponsor

Taipei Medical University WanFang Hospital

Other

Registry information

Official study title

Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Sep 12, 2013
Registry last updated: Nov 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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